The following data is part of a premarket notification filed by Huntleigh Healthcare, Inc. with the FDA for Baby Dopplex 4000, Model Bd 4000.
| Device ID | K990569 |
| 510k Number | K990569 |
| Device Name: | BABY DOPPLEX 4000, MODEL BD 4000 |
| Classification | System, Monitoring, Perinatal |
| Applicant | HUNTLEIGH HEALTHCARE, INC. 227 RT. 33 EAST Manalapan, NJ 07726 |
| Contact | Audrey A Witco |
| Correspondent | Audrey A Witco HUNTLEIGH HEALTHCARE, INC. 227 RT. 33 EAST Manalapan, NJ 07726 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-23 |
| Decision Date | 2000-01-24 |
| Summary: | summary |